Corvus Pharmaceuticals Announces Initiation of Phase 1b Clinical Trial of Soquelitinib for Patients with Hidradenitis Suppurativa
SOUTH SAN FRANCISCO, Calif., Sept. 30, 2026 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that enrollment has begun in its Phase 1b clinical trial of soquelitinib for the treatment of patients with hidradenitis suppurativa.
“The initiation of our Phase 1b hidradenitis suppurativa trial provides an important opportunity to expand the potential of soquelitinib to a wider range of diseases,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “In addition to evaluating safety and efficacy, the trial is designed to evaluate soquelitinib’s ability to modulate Th17-driven disease, complementing the results we have already seen in Th2-driven diseases such as atopic dermatitis. Hidradenitis suppurativa is primarily driven by Th17 cells, which we have shown to be reduced in patients with atopic dermatitis treated with soquelitinib. We look forward to exploring the potential of selective ITK inhibition with soquelitinib to provide an oral and potentially more effective treatment option for hidradenitis suppurativa with a novel mechanism of action.”
The Phase 1b clinical trial is designed to enroll up to 25 patients 18 years and older with moderate to severe hidradenitis suppurativa. All patients will receive a soquelitinib dose of 200 mg twice per day for 12 weeks, followed by a 90-day follow-up period with no treatment. The primary endpoint of the trial is safety and tolerability. The key efficacy endpoint is the proportion of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 50/75 at week 12, and the trial will also evaluate skin and blood biomarkers.
This is the fourth indication under clinical development for soquelitinib, which is also in a registrational Phase 3 trial for relapsed/refractory peripheral T cell lymphoma (PTCL), a Phase 2 trial (SIERRA1) for moderate to severe atopic dermatitis (AD), and a Phase 2 trial for autoimmune lymphoproliferative syndrome (ALPS). Corvus also plans to initiate a Phase 2 clinical trial of soquelitinib in patients with asthma later this year.
About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of immune diseases and cancer. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Soquelitinib is being evaluated in a registrational Phase 3 clinical trial for relapsed/refractory PTCL, a Phase 2 clinical trial for the treatment of atopic dermatitis, and a Phase 1b clinical trial for hidradenitis suppurativa. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com or follow the Company on LinkedIn.
About Hidradenitis Suppurativa1
Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by painful lesions such as deep-seated nodules, abscesses, skin tunnels, and fibrotic scars. The condition’s impact extends beyond physical discomfort, with associated pain, drainage, malodor, and scarring often leading to profound negative psychosocial implications for affected individuals. Treatments include topical therapies, oral therapies, systemic injectable biologic therapies, and direct interventions. HS is associated with elevated levels of Th17 cells compared to regulatory T cells (Tregs), leading to high levels of IL-17 and other cytokines that cause inflammation.
About Soquelitinib
Soquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections, and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. Recent studies have demonstrated that ITK controls a switch between the differentiation of Th17 proinflammatory cells and T regulatory suppressor cells. Inhibition of ITK leads to a shift toward T regulatory cell differentiation, which has the potential to suppress autoimmune and inflammatory reactions. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with autoimmune and allergic diseases and in cancers, including solid tumors. Based on results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas (published in Blood), which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company is enrolling a registrational Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed/refractory PTCL. Soquelitinib is also now being investigated in a randomized placebo-controlled Phase 2 clinical trial in patients with atopic dermatitis and a Phase 1b clinical trial in patients with hidradenitis suppurativa. A publication describing the chemistry, enzymology, and biology of soquelitinib appeared in npj Drug Discovery in December 2024 and is available online at the Nature website and on the Publications and Presentations page of the Corvus website.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the potential safety, tolerability, clinical benefit, and efficacy of the Company’s product candidates, including soquelitinib; the potential use of soquelitinib to improve therapy for a broad range of patients with T cell lymphoma, atopic dermatitis, hidradenitis suppurativa, other immune diseases, and cancers; and clinical strategy and the design of clinical trials, including the timeline for initiation, target or expected number of patients to be enrolled, dose levels, and other product development milestones. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may,” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the Securities and Exchange Commission on August 6, 2026, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of its product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.
INVESTOR CONTACT:
Zack Kubow
Vice President, Investor Relations and Corporate Communications
Corvus Pharmaceuticals, Inc.
investors@corvuspharma.com
MEDIA CONTACT:
Julia Stern
Real Chemistry
media@corvuspharma.com
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1 https://www.ncbi.nlm.nih.gov/books/NBK534867/
